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Richard J. Obiso, PhD operating as Avila Herbals, LLC, a clinical investigator and sponsor of an investigational drug study, failed to comply with federal regulations governing clinical investigations under 21 CFR 312 and the Federal Food, Drug, and Cosmetic Act. The FDA's inspection from July 12-26, 2021 identified objectionable conditions, including a failure to submit a required Investigational New Drug (IND) application for conducting the clinical investigation. Despite Avila Herbals' written response to the FDA's Form 483 observations in August 2021, the company did not adequately address the violations related to human subject protection and investigational drug conduct requirements.